Scientist, Cell Bioassays

Role Summary

Lead the organization's effort on test method development, validation, transfer and training with focus on cell-based and ligand binding assays using advanced systems (i.e., Luminex, FACS, ELISA), clinical pathology using basic systems (i.e., COBAS, STA, DXC, SYSMEX) and in-vitro cytotoxicity and genotoxicity assays to support the delivery of the organization's study pipeline in the area of pre-clinical toxicology and pharmacology.

Provide technical leadership to the analysts in the Cell Bioassays department and support for day-to-day quality control operations.

As a technical subject matter expert, coordinate and liaise with cross-functional units and stakeholders (HODs, SDs, Sponsors, global counterparts) on the testing strategy and execution delivering to the study requirements.

Participate in evaluating and technical exchange with third party laboratories to ensure outsourced projects meet technical and regulatory requirements.

Review and approve test results and assist in study planning for the Cell Bioassays department in workflow optimization, resourcing, procurement, etc. May conduct routine tests per project requirements and capacity constraints.

Responsibilities

1. Act as a study director for the conduct of studies under Good Laboratory Practices (GLP). Ensure that all documents are prepared according to GLP standards and within the required timeframe. Supervise or perform the experimental phase of the study for both regulatory and exploratory studies. At the end of the study, ensure all documents are completed and participate in internal and external audits.
2. Lead the organization’s effort on test method development/optimization and validation focusing on cell-based and ligand binding assays (i.e. Luminex, FACS, ELISA) for the identification and quantitation of chemical constituents and metabolic biomarkers in complex matrices. Conduct in-vitro assays (AMES, MLA, WST8, NRU) for endpoint procedures using cell and bacterial cultures.
3. Provide technical leadership to the analysts in the Cell Bioassays department in the relevant technical domain; conduct training for junior analysts and new hires; provide first-line technical support for daily smooth quality testing.
4. Coordinate outsourced bioassay activities at third party laboratories. Participate in evaluating and technical exchange with third party laboratories to ensure outsourced projects meet technical and regulatory requirements.
5. Act as SME in the technical domain and be the point person to coordinate and liaise with cross-functional units and stakeholders (HODs, SDs, Sponsors and global counterparts) on the testing strategy and execution. Foster a culture of collaboration and enable frequent technical exchange across the network.
6. Review and approve test results and assist in study planning for the Cell Bioassays department in workflow optimization, resourcing, procurement, etc.
7. Conduct routine tests per project requirements and capacity constraints, and be assigned with operational tasks and improvement projects. The routine measurements include performing cytotoxicity assays under the scope of ISO 17025.

Requirement

1. At least Bachelor Degree / M.Sc. in Chemistry, Life Sciences or related technical/scientific discipline is preferred.
2. Minimum 3 years relevant experience with technical and scientific knowledge focusing on bioassays method development, validation and laboratory operations, with a CRO, R&D unit within pharmaceutical or healthcare industries, or translational research organizations.
3. In-depth knowledge and preferably hands-on experience in workflows related to toxicology studies and life science research.
4. Must possess experience in conducting studies under Good Laboratory Practices (GLP).
5. Independent ability to develop, optimize, and validate assays such as Luminex, FACS, and ELISA-based methods in complex matrices.
6. Understanding of regulatory guidelines such as FDA, ICH, OECD GLP, and TGs related to in vivo toxicology studies and method validation.
7. Preferably hands-on experience with Clinical Pathology systems (COBAS, STA, SYSMEX, DXC, BIOANALYZER).
8. Proficiency with ELN, SDMS, and LIMS in a regulated environment is a strong plus.
9. Self-starter and highly motivated individual with excellent communication and influencing skills. Must be able to manage multiple diverse projects simultaneously.
10. Good command of spoken and written English.
11. Proficient in MS Word, Excel, and PowerPoint.